US health authorities reported Friday that Merck’s experimental pill against Covid-19 is effective against the virus, but external expert opinion will be sought about risks among pregnant women, such as possible birth defects and other problems.
The Food and Drug Administration (FDA) published its review of the pill ahead of a public meeting next week where academic and other experts will weigh in on its safety and efficacy. The agency is not obligated to follow the group’s advice.
FDA scientists said their review identified several potential risks, including possible toxicity and birth defects. Given those risks, the FDA will ask its advisers if the drug should be avoided during pregnancy or if it might be available in certain cases.
Then, FDA said the pill would carry warnings about its risks during pregnancyBut doctors would still have the option of prescribing it in certain cases where its benefits could outweigh the risks to patients.
Given the security concerns, the FDA said Merck agreed the drug would not be used in children.
What’s more, FDA raised concerns that Merck’s drug might cause small changes in the spike protein characteristic of coronavirus, which it uses to penetrate human cells. In theory, the FDA warned, those changes could lead to dangerous new variants.
Regulators also noted that Merck collected much less overall safety data on its new drug than those collected for other therapies against Covid-19.
The FDA will ask its independent advisers to discuss all of these issues and They will then vote on whether the pill’s overall benefits outweigh its risks.
All coronavirus drugs currently authorized by the FDA require an injection or intravenous line, which limits their use because they can only be applied by health professionals. If licensed, Merck’s drug would be the first drug that patients could take at home to ease symptoms and speed recovery. The pill is already licensed for emergency use in the UK.
The meeting marks the first time that regulators publicly review a new drug against Covid-19, reflecting the intense interest and scrutiny of a pill that could soon be used by millions of Americans.